Optimized Caloric-proteic Nutrition in Critically Ill Patients

Critically Ill Clinical Trial

Official title:

Optimized Caloric-proteic Nutrition in Critically Ill Patients: Impact on Short and Long-term Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060668
• Other study ID #: HSaoDomingos
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2017
• Source: Hospital Sao Domingos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this prospective randomized controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and a high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day and protein intake usually recommended to critically ill patients (1.4 to 1.5 grams/kg/day).

Description:

OBJECTIVES

To evaluate the effect of nutritional therapy with caloric intake determined by indirect calorimetry and high protein intake (2.0 to 2.2 g/kg/day) compared to nutritional therapy with 25 kcal/kg/day and 1.4 to 1, 5 g/kg/day of protein on short-term outcomes and physical component (PCS) of quality of life after 3 and 6 months of randomization in severe ICU patients.

The primary objective will be the evaluation of the physical component summary (PCS) of SF-36 (Short Form 36), a questionnaire used to evaluate quality of life, validated for the Brazilian population. Patients will be assessed at least 3 and 6 months after randomization.

Secondary objectives: Measurement of handgrip strength measured on the 7th and 14th day of the study and on discharge from the ICU, ICU mortality, hospital mortality, mechanical ventilation time and length of stay in the ICU.

METHODS

The study will include patients over 18 years of age, not pregnant, submitted to mechanical ventilation, whose expectation of stay in the ICU is greater than 3 days.

The sample size was calculated based on the following parameters: patient population under mechanical ventilation, 528, 15% relative risk reduction in the evaluation parameter of the SF-36 tool, Level of significance (α) of 5%, test power of 80%, thus the number of individuals to be sampled will be 294, i.e., two groups of 147 patients. A computer-generated list for randomization and sequentially numbered opaque sealed envelopes is used. The level of significance to reject the null hypothesis will be 5%, that is, a value of p <0.05 will be considered as statistically significant.

Informed consent was obtained from the patient or a next of kin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Critically ill patients Mechanically ventilated Expected length in the ICU > 3 days

Exclusion Criteria:

• Pregnancy Requirement for inspired oxygen (FIO2) > 0.60 High output bronchopleural fistula

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Other:
• Peptamen intense
Study group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein
• Novasource senior
Control group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein

Locations

Country	Name	City	State
Brazil	Hospital Sao Domingos	Sao Luis	MA

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Domingos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCS of SF-36	Physical component summary of Short Form 36	6 months after randomization
Secondary	Handgrip strength	Measured using a calibrated dynamometer	7th, 14th after admission and up to 30 days
Secondary	ICU mortality	ICU outcome	Up to 30 days
Secondary	Hospital mortality	Hospital outcome	Up to 6 months